If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to
transform the lives of patients and their families. We are dedicated to developing
life-changing medicines for people with serious diseases — often with limited or no
therapeutic options. We have a diverse portfolio of marketed medicines, including leading
therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development
advancements across our robust pipeline of innovative therapeutics in oncology and
neuroscience. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit
www.jazzpharmaceuticals.com
for more information.
Brief Description:
The Process Technician Senior Coordinator is required to assist in development and manufacture of research pharmaceutical formulations for use in clinical trials, as well as assisting in all commercial
manufacturing and packaging processes within Botanical Drug Product (BDP), including Clinical Trial packing using a series of well-defined and documented manufacturing procedures whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (c GMP) requirements.
Essential Functions/Responsibilities
Quality is a primary focus to ensure all aspects of c GMP are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:
The job holder is responsible for maintaining c Gx P and EH&S knowledge applicable to the job.
Execute manufacture of clinical formulations.
Maintenance of the manufacturing facility, including cleaning and 6 S.
Ensure delivery against schedule, for all production activities.
Assist in the departmental controlled drug reconciliation.
Ensure all Production batch documentation has been processed in accordance with c GMP and current procedures.
To perform a leading and proactive role within the production areas to ensure procedures are followed correctly and tasks completed in a timely manner.
Perform routine micro testing in the GMP facilities
Liaising with other departments regarding production scheduling, including supply chain, warehouse, engineering, Pharm Dev, QC and QA.
Training of other technicians on new processes/changes to manufacturing techniques.
Identifying areas for improvement and implementing these improvements where applicable across all Production processes/working practices.
Completing additional tasks assigned by production management that are outside the core duties described above.
Required Knowledge, Skills, and Abilities
Carries out their work in a way that will not adversely affect their own, or others, health, safety and security or the environment and reports any shortcomings in company arrangements.
Responsible all aspects of the manufacturing processes to ensure all product are made accordance with c GMP standards, both as an initiator and checker.
Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks.
Complete area/equipment cleaning procedures to high standards as illustrated in c GMP practices.
The job holder may be called upon to provide cover for other internal departments, when the PDMF production schedule allows.
Ensures that all activities undertaken comply with c GMP and EH&S standards as detailed in relevant SOP’s and working practices.
Authors and updates batch documentation, standard operating procedures and associated forms.
Responsible for the completion of quality related documentation, such as deviations, CAPA’s, protocols and change controls.
The nature of the work requires the job holder to be flexible, with regards to working hours to ensure that they are available to complete a production process should it overrun.
Trains and coaches new starters (re-train individuals) in Production manufacturing and packaging processes.
Looks for areas of improvement across all Production manufacturing and packaging processes, in order to improve efficiency and reduce costs.
Informs department management of any atypical events/deviations immediately.
Executes additional tasks in order to meet department objectives.
Potential to act as the Production department EH&S representative and undertake all of the tasks associated with that role.
Potential to take responsibility for consumable and critical to quality ordering within the department. Required/Preferred Education and Licenses
Minimum of 3 years experience gained in a regulated production environment, ideally within the pharmaceutical/chemical or food industry.
Ideally hold qualifications gained in the Pharmaceutical industry i.e. NVQ’s or similar
Displays the attributes encompassed in the company values and encourages their development in others.
Good level of numeracy.
Good communication skills including written.
A good working knowledge of standard Microsoft packages, i.e. Excel and Word.
Excellent attention to detail.
Develops and maintains positive working relationships with key stakeholder groups, both internal and external.
Prepared to challenge the norm and look for areas of improvement, share own ideas and information.
Good team worker assists colleagues as and when required.
Demonstrates a ‘can do’ attitude. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html .